BLU-5937: First-in-Human, Single and Multiple Doses Escalation, Safety, Tolerability, Pharmacokinetics and Food Effect

A Double-Blind, Placebo Controlled, Randomized, Adaptive, First-in-Human Study to Assess, Safety, Tolerability, Pharmacokinetics and Food Effect of Single and Multiple Doses of BLU-5937 Administered Orally in Healthy Male and Female

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 using a double blind, placebo controlled, randomized, adaptive, single center study design. The influence of food on the pharmacokinetics of BLU-5037 will also be investigated.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Drug: BLU-5937; Drug: Placebo

Detailed Description

BLU-5937 is a selective P2X3 receptor antagonist being developed for the treatment of chronic cough. This Phase 1 study will investigate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of BLU-5937 administered orally to healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Mount-Royal, Quebec, Canada, H3P 3P1
      • Alta Sciences Algorithme Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult male and/or female (non-childbearing potential or, for women of childbearing potential, using 2 forms of acceptable birth control or agreed to abide by true abstinence),
• Age: 18 to 55 years (inclusive).
• Body mass index (BMI) : ≥18.5 and ≤30 kg/m².
• Non or ex smoker.

Exclusion Criteria:

• Any findings from the medical examination (including medical history, physical examination, vital signs, laboratory tests and ECG) outside from normal and deemed by the investigator to be clinically significant.
• Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of the investigator would put into question the status of the volunteer as healthy.
• Volunteers who took an Investigational Product in the 28 days prior to the first study drug administration.
• Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration.
• Donation of 500 mL or more of blood in the 56 days prior to the first study drug administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Ascending Doses; Single ascending doses, 6 dose levels	Drug: BLU-5937; BLU-5937 oral tablet; Drug: Placebo; Matching placebo to BLU-5937
Experimental: Multiple Ascending Doses; Multiple ascending doses, 3 dose levels	Drug: BLU-5937; BLU-5937 oral tablet; Drug: Placebo; Matching placebo to BLU-5937

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and severity of treatment emergent adverse events (TEAEs)	Number and severity of TEAEs collected from dosing until follow up 48 hours after last dose	up to 48 hours after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	To assess Cmax of single and multiple ascending oral doses of BLU-5937	up to 48 hours after the last dose
Area under the curve (AUC)	To assess AUC of single and multiple ascending oral doses of BLU-5937	up to 48 hours after the last dose
Maximum plasma concentration (Cmax) under fed conditions	To assess Cmax of a single oral dose of BLU-5937 under fed conditions	up to 48 hours after the last dose
Area under the curve (AUC) under fed conditions	To assess AUC of a single oral dose of BLU-5937 under fed conditions	up to 48 hours after the last dose

Collaborators and Investigators

• Sponsor: Bellus Health Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: BUS-P5-703

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No